Unicycive resubmits kidney-drug application with new manufacturer data

Unicycive ($UNCY) resubmitted its US application for oxylanthanum carbonate, an investigational oral phosphate binder for dialysis patients with chronic kidney disease. The package includes manufacturing and quality data from a new third-party supplier, twelve months of product-stability results and laboratory bridging data comparing the new and previous suppliers. The filing seeks to address the manufacturing issues affecting the program.

The company expects the FDA to determine acceptance within 30 days and anticipates a review deadline six months after resubmission. Those timings are management expectations, not an FDA-confirmed decision date. Unicycive says its current cash position provides funding into the second half of 2027. A successful review could reopen the path to commercialization, but the drug remains investigational and submission does not amount to acceptance or marketing authorization.

Sources:

• Issuer release